Report shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards.

FDA Flags Cadwell Industries for CAPAs, Complaints, Design Validation

The facility had no documented plan for verifying the effectiveness, as required by the firm’s CAPA procedure, of at least two CAPAs that had already been marked as effective, according to the Form 483 issued after an August inspection.

The agency’s investigator also found three complaints regarding devices that were returned to Cadwell more than a year ago that had not been evaluated.

In addition, the firm had failed to follow its validation procedure for the IOMAX device as production equivalent devices were not used for testing.